Study of Faslodex With or Without Concomitant Arimidex Versus Exemestane Following Progression on Non-steroidal Aromatase Inhibitors (NSAI)

• ClinicalTrials.gov Identifier: NCT00944918
• Recruitment Status: Completed
• First Posted: July 23, 2009
• Last Update Posted: August 29, 2011
• Sponsor: AstraZeneca
• Information provided by (Responsible Party): AstraZeneca

Study Description

Brief Summary:

A partially-blind, randomised, multicentre phase III trial of Faslodex plus concomitant Arimidex versus Faslodex plus Arimidex-Placebo versus exemestane in postmenopausal locally advanced / metastatic breast cancer patients who have progressed on NSAIs. Randomisation to Faslodex ± Arimidex / Arimidex-Placebo or exemestane will be open (1:1:1). For Faslodex treated patients the randomisation to Arimidex or Arimidex-Placebo will be double-blind.

Condition or disease	Intervention/treatment	Phase
Progression-free Survival	Drug: fulvestrant; Drug: anastrozole; Drug: exemestane	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Partially-blind Phase III Randomised Trial of Fulvestrant (Faslodex) With or Without Concomitant Anastrozole (Arimidex) Compared With Exemestane in Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-steroidal Aromatase Inhibitors
• Study Start Date: December 2008
• Actual Primary Completion Date: June 2011
• Actual Study Completion Date: June 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; fulvestrant and anastrozole	Drug: fulvestrant; Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression.; Other Name: Faslodex; Drug: anastrozole; Tablet, oral, once daily until disease progression.; Other Name: Arimidex
Experimental: 2; fulvestrant and placebo	Drug: fulvestrant; Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression.; Other Name: Faslodex
Active Comparator: 3; exemestane alone	Drug: exemestane; Tablet, oral, once daily until disease progression.; Other Name: Aromasin

Outcome Measures

Primary Outcome Measures :

1. Progression-free survival [ Time Frame: every 3 months during treatment and, at time of discontinuation from treatment ]

Secondary Outcome Measures :

1. Objective complete response (CR) and partial response (PR) rate [ Time Frame: every 3 months during treatment and, at time of discontinuation from treatment ]
2. Duration of response [ Time Frame: every 3 months during treatment and, at time of discontinuation from treatment ]
3. Clinical benefit (i.e., 6-month CR, PR, and stable disease) rate [ Time Frame: every 3 months during treatment and, at time of discontinuation from treatment ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the breast.
• Metastatic disease must be measurable or evaluable
• Relapsed or progressed during prior treatment with single-agent NSAI, meeting either of the following criteria:
• NSAI given as adjuvant therapy that lasted ≥ 12 months OR
• Achieved an objective CR, PR, or SD that that lasted ≥ 6 months after prior 1st-line
• Female postmenopausal patients

Exclusion Criteria:

• Hormone receptor status1. ER -ve and PgR NK2. ER-ve and PgR -ve3. ER NK
• Prescribed Tamoxifen for metastatic disease
• Rapidly progressive visceral disease
• Patients with malignancies within the last 5 years.

Contacts and Locations

Locations

Korea, Republic of

Research Site

Ilsan, Korea, Republic of

Research Site

Seoul, Korea, Republic of

Sponsors and Collaborators

AstraZeneca

Investigators

• Principal Investigator: Young-Huck Im; Professor(Samsung Medical Center)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Johnston SR, Kilburn LS, Ellis P, Dodwell D, Cameron D, Hayward L, Im YH, Braybrooke JP, Brunt AM, Cheung KL, Jyothirmayi R, Robinson A, Wardley AM, Wheatley D, Howell A, Coombes G, Sergenson N, Sin HJ, Folkerd E, Dowsett M, Bliss JM; SoFEA investigators. Fulvestrant plus anastrozole or placebo versus exemestane alone after progression on non-steroidal aromatase inhibitors in postmenopausal patients with hormone-receptor-positive locally advanced or metastatic breast cancer (SoFEA): a composite, multicentre, phase 3 randomised trial. Lancet Oncol. 2013 Sep;14(10):989-98. doi: 10.1016/S1470-2045(13)70322-X. Epub 2013 Jul 29.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00944918
• Other Study ID Numbers: 9238UK/0005
• First Posted: July 23, 2009
• Last Update Posted: August 29, 2011
• Last Verified: August 2011

Keywords provided by AstraZeneca:

Breast Cancer

Additional relevant MeSH terms:

Disease Progression; Disease Attributes; Pathologic Processes; Fulvestrant; Anastrozole; Exemestane; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Estrogen Receptor Antagonists; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action